UK health regulator invites feedback on clinical trials regulations

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting interested parties to provide feedback on Clinical Trial Regulation guidance documents.

Following Britain’s referendum on European Union membership, which resulted in a vote for “Brexit,” the MHRA continues to play a full, active role in European regulatory procedures. The UK is assessing the potential impact on the regulatory framework of the decision to leave the EU. At present, it continues with its program for implementing the Clinical Trials Regulations and the UK remains an EU member state with the rights and responsibilities this entails.

This consultation seeks the views of stakeholders – and other interested parties – on the document regarding “Risk proportionate approaches in clinical trials.” The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.